LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.
In remarks in Geneva on Tuesday at the World Health Organization's 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances, Hospira SVP and chief scientific officer Sumant Ramachandra said that European regulators had approved biosimilars with the same generic names as their reference biologics for more than six years in a system that had proved effective. Ramachandra's remarks were from a paper that the drug maker issued last week.
The question of whether biosimilars should carry the same generic names as their reference products or carry special names has emerged as a key issue as the Food and Drug Administration works to create an abbreviated approval pathway for biosimilars, as mandated by provisions of the Patient Protection and Affordable Care Act. Biotech companies, which stand to lose billions in sales when cheaper biosimilar versions of their products enter the market — according to IMS Health, biosimilars in Europe have helped lower costs by 20% to 30%, and the Generic Pharmaceutical Association estimates they could safe the U.S. healthcare system $20 billion per year — maintain that because biosimilars will be made using separate cell lines, there is a risk that they will be different in terms of efficacy and safety.
Ramachandra also said that biosimilars have been successfully tracked in the marketplace using their brand names, meaning that a separate name isn't necessary for keeping track of them, and that the Affordable Care Act didn't include language requiring separate generic names. Furthermore, separate generic names could create confusion among the clinicians who rely on international and local standards to fill prescriptions, potentially resulting in safety and medication access issues.
“Biosimilars represent an enormous opportunity to put many of today’s most life-changing medicines in reach for millions more patients,” GPhA president and CEO Ralph Neas said. “It is critical that any decision on naming these products does not jeopardize that potential. That is why we are so pleased that WHO is taking a thoughtful and deliberate approach to reviewing this issue.”